DRUGS & SUPPLEMENTS
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4-Way Fast Acting (Naphazoline Hydrochloride) OPHTHALMIC SOLUTION USP, 0.1%
Naphazoline HCl, an ocular vasoconstrictor, is an imidazoline derivative sympathomimetic amine. The active ingredient is represented by the structural formula:
Chemical Name:2-(1-naphthylmethyl)-2-imidazoline monohydrochlorideVASOCON REGULAR ophthalmic solution is a sterile solution containing 1 mg/mL 4-Way Fast Acting (Naphazoline Hydrochloride) in an isotonic solution containing polyethylene glycol 8000, sodium chloride, polyvinyl alcohol, edetate disodium and purified water; preserved with benzalkonium chloride. Hydrochloric acid and/or sodium hydroxide added to adjust pH. It has a pH of 5.5 to 7.0.CLINICAL PHARMACOLOGY
Naphazoline constricts the vascular system of the conjunctiva. It is presumed that this effect is due to direct stimulation action of the drug upon the alpha adrenergic receptors in the arterioles of the conjunctiva resulting in decreased conjunctival congestion. Naphalozine belongs to the imidazoline class of sympathomimetics.
INDICATIONS AND USAGE
4-Way Fast Acting (Naphazoline Hydrochloride) REGULAR is indicated for use as a topical ocular vasoconstrictor.
Contraindicated in the presence of an anatomically narrow angle or in narrow angle glaucoma or in persons who have shown hypersensitivity to any component of this preparation.
Patients under therapy with MAO inhibitors may experience a severe hypertensive crisis if given a sympathomimetic drug. Use in children, especially infants, may result in CNS depression leading to coma and marked reduction in body temperature.
Use with caution in the presence of hypertension, cardiovascular abnormalities, hyperglycemia (diabetes), hyperthyroidism, ocular infection or injury and when other medications are being used.
Patients should be advised to discontinue the drug and consult a physician if relief is not obtained within 48 hours of therapy, if irritation, blurring, or redness persists or increases, or if symptoms of systemic absorption occur, i.e., dizziness, headache, nausea, decrease in body temperature, or drowsiness.
To prevent contaminating the dropper tip and solution, do not touch the eyelids or the surrounding area with the dropper tip of the bottle. If solution changes color or becomes cloudy, do not use.Drug Interactions
Concurrent use of maprotiline or tricyclic antidepressants and naphazoline may potentiate the pressor effect of naphazoline. Patients under therapy with MAO inhibitors may experience a severe hypertensive crisis if given a sympathomimetic drug..
Pregnancy Category C
Animal reproduction studies have not been conducted with naphazoline. It is also not known whether naphazoline can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Naphazoline should be given to a pregnant woman only if clearly needed.
If is not known whether naphazoline is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when naphazoline is administered to a nursing woman.
Safety and effectiveness in children have not been established. See “WARNINGS” and “CONTRAINDICATIONS”.
Mydriasis, increased redness, irritation, discomfort, blurring, punctate keratitis, lacrimation, increased intraocular pressure.
Dizziness, headache, nausea, sweating, nervousness drowsiness, weakness, hypertension, cardiac irregularities, and hyperglycemia.
DOSAGE AND ADMINISTRATION
Instill one or two drops in the conjunctival sac(s) every three to four hours as needed.
4-Way Fast Acting (Naphazoline Hydrochloride) REGULAR (naphazoline hydrochloride ophthalmic solution USP, 0.1%): 15 mL plastic squeeze bottle with dropper tip. NDC 58768-844-15 To be dispensed only in original, unopened container. Store at controlled room temperature 15°-30°C (59°-86°F).
CAUTION: Federal law prohibits dispensing without prescription. Mfd. by OMJ Pharmaceuticals, Inc.,San Germán, P.R., 00683 for:CIBA VisionOphthalmics®_Atlanta, Georgia 301556072-A
(in each tablet)
Dexbrompheniramine Maleate 2 mg
4-Way Fast Acting (Phenylephrine Hydrochloride) Hydrochloride 10 mg
Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
Do not exceed recommended dosage.
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
If pregnant or breast-feeding, ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away.
|Adults and children 12 |
years of age and over:
|1 tablet every 4 to 6 |
hours, not to exceed
6 tablets in 24 hours
|Children 6 to under 12 |
years of age:
|1/2 tablet every 4 to |
6 hours, not to
exceed 3 tablets in
|Children under 6 years |
|Consult a doctor |
Store at 15° - 30°C (59° - 86°F). Supplied in a tight, light-resistant container with a child-resistant cap. 4-Way Fast Acting (Phenylephrine Hydrochloride) Tablets are dark purple, caplet-shaped, scored tablets, debossed "Poly" bisect "782" on one side and plain on the other.
colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 aluminum lake, dibasic calcium phosphate dihydrate, FD &C Blue #1 aluminum lake, magnesium stearate, and silicified microcrystalline cellulose.
Quitman, MS 39355 Rev. 02/12
The packaging below represents the labeling currently used.
Principal display panel and side panel for 60 tablets label:
4-Way Fast Acting (Phenylephrine Hydrochloride)
Antihistamine - Nasal Decongestant
Each tablet contains:
Dexbrompheniramine Maleate...2 mg
4-Way Fast Acting (Phenylephrine Hydrochloride) Hydrochloride...10 mg
Dosage: See product foldout for full prescribing information.
Tamper evident by foil seal under cap. Do not use if foil seal is
broken or missing.
KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.
Store at controlled room temperature between 15°-30°C (59°-86°F).
Quitman, MS 39355
4-Way Fast Acting (Phenylephrine Hydrochloride) Tablets Packaging 4-Way Fast Acting (Phenylephrine Hydrochloride) Tablets Packaging
For use when an oral antihistamine is needed.
Can be provided to horse: 1/2 ounce (1 tablespoon) per 1000lbs body weight. Can be repeated at 12 hour intervals as needed, or as recommended by a veterinarian. The large end of the enclosed scoop measures 1 tablespoon.
This product contains 4-Way Fast Acting (Pyrilamine Maleate) Maleate which may be prohibited in certain competition. Caution must be taken when used on competition horse subject to drug testing. Check with the event sanction body for the necessary withdrawal time.
EACH OUNCE CONTAINS (minimum): 4-Way Fast Acting (Pyrilamine Maleate) Maleat USP 600mg, in a palatable base.
FOR ANIMAL USE ONLY.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Keep lid tightly closed and store in a dry place Do not store above 30 C (86 F).
4-Way Fast Acting (Pyrilamine Maleate)
Net Contents: 20 ounces (567 Gm)
Depending on the reaction of the 4-Way Fast Acting after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider 4-Way Fast Acting not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is 4-Way Fast Acting addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology